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Trial record 2 of 2 for:    Recruiting, Not yet recruiting, Available Studies | Thrombosis | UCSD OR UC San Diego OR VA San Diego

Randomized Study to Assess the Safety, Pharmacokinetics/Dynamics of DS-1040b in Subjects With Acute Submassive Pulmonary Embolism

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ClinicalTrials.gov Identifier: NCT02923115
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:
This is a Phase 1b, double-blind (Principal Investigators, study subjects, Sponsor, Academic Research Organization ARO and Clinical Research Organization CRO blinded), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, efficacy, tolerability, pharmacokinetics PK, and pharmacodynamics PD of DS-1040b in subjects with acute submassive pulmonary embolism.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Thrombotic Disease Drug: DS-1040b Drug: placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b When Added to Standard of Care Anticoagulation Therapy in Subjects With Acute Submassive Pulmonary Embolism
Study Start Date : September 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DS-1040b
9 subjects each in Cohorts 1 and 2, and 15 subjects each in Cohorts 3, 4, 5, and 6.
Drug: DS-1040b
injection

Placebo Comparator: placebo

9 subjects each in Cohorts 1 and 2, and 5 subjects each in Cohorts 3, 4, 5, and 6.

0.9% Sodium Chloride Injection

Drug: placebo
0.9% Sodium Chloride Injection




Primary Outcome Measures :
  1. Number of participants with clinically relevant bleeding [ Time Frame: baseline (Day 0) to Day 30 ]

Secondary Outcome Measures :
  1. Change from baseline in pulmonary embolism PE thrombus volume [ Time Frame: baseline (Day 0) to Day 30 ]
  2. Number of serious adverse events [ Time Frame: baseline (Day 0) to Day 30 ]
  3. Severity of serious adverse events [ Time Frame: baseline (Day 0) to Day 30 ]
  4. Number of treatment emergent adverse events [ Time Frame: baseline (Day 0) to Day 30 ]
  5. Severity of treatment emergent adverse events [ Time Frame: baseline (Day 0) to Day 30 ]
  6. Area Under the Concentration Curve (AUC) for DS-1040b [ Time Frame: baseline (Day 0) to Day 30 ]
  7. Terminal elimination half-life (t1/2) of DS-1040b [ Time Frame: baseline (Day 0) to Day 30 ]
  8. Maximum concentration (Cmax) of DS-1040b [ Time Frame: baseline (Day 0) to Day 30 ]
  9. Time of maximum concentration (Tmax) for DS-1040b [ Time Frame: baseline (Day 0) to Day 30 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects, age 18 to 75 years admitted to hospital with a clinical diagnosis of acute PE categorized as low risk or intermediate-risk or submassive PE and for whom catheter-based therapy is not planned;
  • Subjects must have a CTA scan confirming the PE diagnosis and with at least one measurable index lesion in a segmental or larger pulmonary artery prior to randomization;
  • Subjects should be in otherwise satisfactory health in the opinion of the Investigator;
  • Subjects must be able to provide written informed consent.

Exclusion Criteria:

  • Subjects with acute PE categorized as high-risk or massive, or who are hemodynamically unstable, evidenced by a heart rate > 120 /min and a systolic blood pressure (SBP) of < 90 mmHg for more than 15 consecutive minutes or a drop in SBP of > 40 mmHg since presentation;
  • Subjects for whom use of a thrombolytic, either systemic or via catheter, is planned;
  • Subjects with PE lesions only in the sub-segmental or smaller arteries;
  • Subjects receiving any vitamin K antagonists (VKAs) prior to randomization or receiving more than 36 hours treatment with LMW(low molecular weight Heparin) in therapeutic doses prior to randomization;
  • Subjects who had a prior intracranial hemorrhage, known arteriovenous malformation or aneurysm, head trauma, or evidence of active bleeding;
  • Subjects who within 48 hours of randomization have used an anti-Factor IIa agent such as dabigatran or an anti-FXa agent such as rivaroxaban, apixaban, or edoxaban;
  • Subjects who within 21 days prior to randomization have had gastrointestinal or genitourinary bleeding;
  • Subjects who within 14 days prior to randomization have had major surgery or a lumbar puncture (or epidural steroid injection);
  • Subjects with diagnosed active liver disease or with elevation of liver enzymes/bilirubin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923115


  Show 47 Study Locations
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Investigators
Study Director: Clinical Study Leader Daiichi Sankyo, Inc.

Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT02923115     History of Changes
Other Study ID Numbers: DS1040-B-U107
2015-005211-32 ( EudraCT Number )
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://www.clinicalstudydatarequest.com//. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-DS.aspx
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://www.clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-DS.aspx

Keywords provided by Daiichi Sankyo, Inc.:
Venous thromboembolism
VTE
Pulmonary embolism
PE
Acute Submassive Pulmonary Embolism

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases